New Delhi, Jul 3 (KNN) In a significant move to address recent quality issues and align with global standards, sixty small drug manufacturers in India have enrolled in a government-led modernisation initiative.

The Revamped Pharmaceuticals Technology Upgradation Assistance Scheme (RPTUAS), launched by the Ministry of Chemicals and Fertilisers in March 2024, aims to support existing pharma units in upgrading their facilities to meet World Health Organisation (WHO) Good Manufacturing Practices (GMP).

This initiative is part of a broader effort to comply with revised standards mandated by the Drugs and Cosmetic Act.

The scheme's rollout follows a turbulent period for the Indian pharmaceutical industry. Throughout 2023, several countries raised alarms about Indian-exported cold medications and syrups containing toxic levels of chemicals such as diethylene glycol (DEG) and ethylene glycol (EG). These incidents prompted multiple WHO alerts and led to the Indian government launching probes into implicated firms.

Under the RPTUAS, over 30 of the enrolled companies have already begun upgrading their facilities. The scheme has been designed to be inclusive, extending eligibility to pharmaceutical manufacturing units with turnovers of up to Rs 500 crores, while still prioritising micro, small, and medium enterprises (MSMEs).

Financial incentives offered by the scheme are tiered based on company revenue, ranging from 10 per cent to 20 per cent of investments. The maximum support is capped at Rs 1 crore per unit for the smallest firms.

Eligible activities for upgrade include improvements to HVAC systems, water and steam utilities, testing laboratories, and waste management facilities.

This development comes in the wake of several incidents where Indian pharmaceuticals were linked to fatalities in various parts of the world, including North America, Africa, and Central Asia.

The government has also introduced flexible financing options, moving away from the traditional credit-linked approach to a reimbursement-based subsidy model.

This change, along with the possibility of integrating state government schemes for additional support, is expected to encourage wider participation.

Industry experts view this initiative as a crucial step in rebuilding trust in Indian pharmaceuticals on the global stage. However, they emphasise that consistent implementation and rigorous quality control will be key to long-term success.

As the scheme gains momentum, it remains to be seen how effectively it will address the quality concerns that have plagued the sector.

(KNN Bureau)